FDA 510(k)

チューリウムファイバーレーザー、外科用ファイバー、およびアクセサリーのIPGメディカルファミリー

K番号: K232568 · 2024-03-21

決定日2024-03-21

製品コードGEX

諮問委員会SU （以下のテキストは翻訳されていません。） Policy: medical-regulatory-v1

決定大幅同等

医療機器の概要

IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Ipg Medical Corporation. It received FDA 510(k) clearance on 2024-03-21 under 510(k) number K232568. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

よくある質問

What is the IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and Accessories?

IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and Accessories is a medical device that received FDA 510(k) clearance on 2024-03-21. The listed applicant is Ipg Medical Corporation. The 510(k) number is K232568.

When did IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and Accessories receive FDA 510(k) clearance?

IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and Accessories received FDA 510(k) clearance on 2024-03-21, under 510(k) number K232568.

Who is the listed applicant for IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and Accessories?

The FDA 510(k) record lists Ipg Medical Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and Accessories?

The FDA product code for IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and Accessories is GEX. This falls under the Gastroenterology category.

申請者としてIpg Medical Corporationを記載するその他の記録

K251100IPGTFL-02

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